Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma

Status: Closed to Accrual

This study is a prospective phase II trial of nivolumab in 120 treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) and 40 treatment naïve patients with non-clear cell renal cell carcinoma (nccRCC). The primary objective is to determine the progression-free survival (PFS) rate at one year of nivolumab in patients with treatment-naïve ccRCC based on tumor PD-L1 expression.

• Condition: Advanced renal cell carcinoma
• Intervention:
  • Drug: Nivolumab
  • Drug: Ipilimumab
• Phase: Phase II

For full description, see https://clinicaltrials.gov/study/NCT03117309.

Read a news release about this trial.

 
Abstracts/Posters/Presentations:

•  J Zaemes, M Hugaboom, V Shah, N Haas, D McDermott, O Jegede, M Bilen, M Stein, J Sosman, R Alter, E Plimack, M Hurwitz, C Wu, D Einstein, H Hammers, S Signoretti, D West, T Denize, M Atkins, D Braun. Molecular analysis of the HCRN GU16-260-Cohort A phase II study of first-line (1L) nivolumab (nivo) and salvage nivo + ipilimumab (ipi) in patients (pts) with advanced clear cell renal cell carcinoma (accRCC) (HCRN GU16-260). Poster Presentation, 2024 American Society of Clinical Oncology Annual Meeting. See abstract. 
• N El Ahmar, S Matar, O Jegede, Y Nabil Laimon, V Savla, A Bagheri Sheshdeh, T Denize, R Assaad Mohanna, TK Choueiri, PJ Catalano, DA Braun, NB Haas, HJ Hammers, M Asim Bilen, MN Stein, JA Sosman, CJ Wu, DF McDermott, MB Atkins, S Signoretti. Tumor-infiltrating CD163-positive macrophages and clinical outcomes to first-line nivolumab therapy in patients with advanced clear cell renal cell carcinoma (ccRCC) (HCRN GU16-260). Poster Presentation, 2024 American Society of Clinical Oncology GU. See abstract. 
• M Hugaboom, K Street, N Ruthen, L Wirth, OA Jegede, N Schindler, DF McDermott, E Plimack, J Sosman, NB Haas, M Hurwitz, H Hammers, S Signoretti, MB Atkins, CJ Wu, D Braun. 1017 SLAMF7+ CD8+ exhausted T cell-specific gene signature is associated with resistance to PD1 blockade in renal cell (HCRN GU16-260). Poster Presentation, 2023 SITC. See abstract. 
• MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, J Hawley, JA Sosman, RS Alter, ER Plimack, MC Ornstein, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B). Presented as poster discussion at the 2021 American Society of Clinical Oncology Annual Meeting. See abstract.
• MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, CG Drake, JA Sosman, RS Alter, ER Plimack, BI Rini, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260). Presented as an oral abstract at the 2020 American Society of Clinical Oncology Annual Meeting. See abstract.

Study Contact: studies@hoosiercancer.org; (317) 921-2050.